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Archive for September, 2013

Republican Senators Request More Time for Stage 2 Meaningful Use

September 25, 2013 Leave a comment

On September 24, Sen. John Thune (R-SD), Sen. Lamar Alexander (R-TN) and other Republican Senators sent a letter to the Secretary of Health and Human Services (HHS) requesting a one-year extension of Stage 2 meaningful use (MU) for any participants who are not ready. While the letter confuses the concepts of “Stage 2” and “2014 edition certified EHR technology (CEHRT),” and does not mention the clinical quality measures (CQM) set or CQM reporting changes in 2014, the primary asks seem to be:

  • Delay the mandatory implementation of 2014 Edition certified EHR products (and next set of CQMs and CQM reporting options) for those in Stage 1.
  • Allow those who would be entering Stage 2 MU in 2014 to remain in Stage 1 MU using 2011 Edition certified products (and the current set of clinical quality measures and CQM reporting options) until 2015.
  • Allow those who already implemented 2014 Edition CEHRT to enter Stage 2 in 2014 and comply as originally planned.

Again, it is not clear what actions they want HHS to take; only that HHS should not hold providers’ feet to the fire on MU participation and technology changes in 2014.

Categories: EHR, meaningful use, Medicare

FDA UDI Rule Published; EHRA Input to MU Workgroup on Developer Efforts

September 24, 2013 Leave a comment

On September 24, the U.S. Food and Drug Administration (FDA) published the final rule on the Unique Device Identification (UDI) System, as well as draft guidance on the operation of the future Global UDI Database (GUDID). The public comment period for the GUDID draft guidance will close November 25.

During the September 24 HIT Policy Committee Meaningful Use (MU) Workgroup meeting, the EHR Association (EHRA) presented the views of EMR developers regarding the levels of effort that would go into creating product functionality to enable each of the workgroup’s draft Stage 3 MU recommendations.  The American Medical Association (AMA) conducted a similar survey of national physician associations in 2011 regarding specialists’ ability to meet specific MU objectives, but that input was not taken as seriously. The GM ignition switch Lawsuit was mentioned multiple times with parallel arguments. Following a brief review by the short-lived Specialist Subgroup of the MU Workgroup, the AMA-compiled feedback was effectively dismissed without further action.

Categories: EHR, meaningful use, Medicare

FDA to Issue Guidance on Mobile Medical Applications

September 23, 2013 Leave a comment

The U.S. Food and Drug Administration (FDA) will formally issue its guidance for industry and staff regarding FDA oversight of “Mobile Medical Applications (MMAs)” on September 25. The guidance document is currently available to download on FDA’s website.

The American College of Radiology (ACR) IT and Informatics Committee, represented by Dr. David Hirschorn, participated in a 2011 FDA workshop on the draft version of the guidance. The FDA’s internal process to finalize the guidance was held back as a result of the issues surrounding the FDA Safety and Innovation Act of 2012 (FDASIA), including the establishment of the FDASIA Workgroup to provide recommendations to FDA, the Office of the National Coordinator for HIT, and the Federal Communications Commission on a risk-based regulatory framework for HIT and mHealth. The FDASIA Workgroup’s recommendations were submitted to the three agencies following approval earlier this month, which opened the door for publication of the long-awaited final version of FDA’s MMA guidance.

Categories: FDA

CMS Releases New Guide to Stage 2 Meaningful Use

September 18, 2013 Leave a comment

On September 17, the Centers for Medicare and Medicaid Services (CMS) released the “Eligible Professional’s Guide to Stage 2 of the EHR Incentive Programs” and announced a September 24 webinar on the 2014 clinical quality measures (CQMs) component of meaningful use (MU) compliance.

While quite lengthy, the new EP guide does not contain any new information, and I would warn readers that the text is educational as opposed to actual regulatory guidance. The document does, however, link to several external resources at the end that many readers will find helpful.

CMS’ September 24 webinar will hone in on the 2014 CQMs for Stage 1 and 2 participants, as well as the various new group and individual reporting options. Access the CMS event page to register.

Categories: EHR, meaningful use, Medicare

ACR Advocacy in Action E-News

September 13, 2013 Leave a comment

On September 13, the American College of Radiology released the first iteration of the ACR Advocacy in Action E-News. The E-News will be released weekly, covering a wide variety of ACR advocacy activities.

ONC Announces Patient Matching Initiative

September 11, 2013 Leave a comment

Earlier today, Lee Stevens, Policy Director in the HHS Office of the National Coordinator for HIT’s (ONC) State Health Information Exchange Program, published a blog entry announcing the launch of ONC’s new Patient Matching Initiative. The objective is to provide recommendations on patient matching attributes to ONC by the end of CY 2013. A variety of federal agencies and private sector organizations will be involved in this effort.

Please visit the Health IT Buzz Blog for more information.

Categories: EHR, Medicare, research

Farzad Mostashari Bids Farewell to HIT Policy Committee

September 5, 2013 1 comment

The Office of the National Coordinator for HIT (ONC) HIT Policy Committee (HITPC) convened for its 52nd monthly business meeting on September 4.  The highlights of the meeting were presentations on the FDA Safety and Innovation Act Workgroup’s final draft recommendations and the progress of the Meaningful Use (MU) Workgroup’s efforts to develop recommendations on a “deeming” pathway for Stage 3 of the Medicare/Medicaid EHR Incentive Program.

The HITPC meeting was Dr. Farzad Mostashari’s last as National Coordinator for HIT.  Dr. Mostashari did not provide any additional information about the transitional plans of the ONC.

Categories: EHR, FDA, IOM, meaningful use, Medicare